[Federal Register Volume 63, Number 29 (Thursday, February 12, 1998)]
[Notices]
[Pages 7173-7174]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-3504]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97N-0327]
Agency Information Collection Activities; Submission for OMB
Review; Comment Request
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that the
proposed collection of information listed below has been submitted to
the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995 (the PRA).
DATES: Submit written comments on the collection of information by
March 16, 1998.
ADDRESSES: Submit written comments on the collection of information to
the Office of Information and Regulatory Affairs, OMB, New Executive
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn:
Desk Officer for FDA.
FOR FURTHER INFORMATION CONTACT: JonnaLynn P. Capezzuto, Office of
Information Resources Management (HFA-250), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.
SUPPLEMENTARY INFORMATION: In compliance with section 3507 of the PRA
(44 U.S.C. 3507), FDA has submitted the following proposed collection
of information to OMB for review and clearance.
Petition For Administrative Stay of Action--21 CFR 10.35--(OMB
Control Number 0910-0194)--Reinstatement
FDA regulations in 21 CFR 10.35, issued under the authority of
section 701(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
371(a)), set forth the format and procedures by which an interested
person may file a petition for an administrative stay of action.
Respondents to this collection of information are interested
persons who choose to file a petition for an administrative stay of
action. Such a petition must: (1) Identify the decision involved; (2)
state the action requested, including the length of time for which a
stay is requested; and (3) include a statement of the factual and legal
grounds on which the interested person relies in seeking the stay. The
information provided in the petition is used by the agency to determine
whether the requested stay should be granted.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden1
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Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
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10.35 7 1 7 100 700
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 7174]]
The burden estimate for this collection of information is based on
FDA's experience with petitions for administrative stay of action over
the past 3 years. Agency personnel responsible for processing the
filing of petitions for administrative stays of action estimate that
seven such petitions are received by the agency annually, with each
requiring approximately 100 hours of preparation time.
Dated: February 4, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-3504 Filed 2-11-98; 8:45 am]
BILLING CODE 4160-01-F